# FDA 483 - Micro Stamping Corp - February 25, 2020

Source: https://www.globalkeysolutions.net/records/483/micro-stamping-corp/4c48e0e2-48e6-42d5-8667-3cf79028c907

> FDA 483 for Micro Stamping Corp on February 25, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Micro Stamping Corp
- Inspection Date: 2020-02-25
- Product Type: device
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Mico Stamping Corp in Somerset, NJ, a contract manufacturer, revealed significant deficiencies in their quality system. The firm failed to adequately establish corrective and preventive action procedures and did not properly investigate customer complaints. Additionally, a critical manufacturing process was not adequately validated, leading to high rework rates for commercially distributed products.

## Related Documents

- [483 - 2023-01-18](https://www.globalkeysolutions.net/records/483/micro-stamping-corp/f62f9ee1-d89c-4c38-92ea-2b9402994e64)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/gobiga-vanniyasingam/db801a84-a834-4439-9a0a-c37032c95317)

Company: https://www.globalkeysolutions.net/companies/micro-stamping-corp/ce3f1bf4-77e0-487f-8a7c-42d9465ae096

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248